The present invention relates generally to catheter devices and more particularly to urinary catheters having protective sheaths, lubricating means, and means for facilitating insertion of the catheter into the urethra.
It has become relatively commonplace for the occasional, intermittent or periodic catheterization of an individual's urinary bladder to be employed, as opposed to placement and maintenance of an indwelling catheter that continuously drains urine from the bladder. Short term, or repeated catheterization is appropriate, or even required, for many persons who are in a hospital setting, a nursing home, doctor's office, rehabilitation facility or in the home. For example, a patient is sometimes catheterized to treat such conditions as urinary retention, the inability to evacuate urine, or for the purpose of obtaining a sterile urine specimen from a patient in a doctor's office.
The need for intermittent catheterization of an individual sometimes arises due to problems typically associated with long term use of indwelling catheters, such as infections, urethral damage, bladder damage. Long term use of an indwelling catheter is also a risk factor for bladder cancer. This is often the case for persons having a neurogenic urinary condition, such as in a spinal cord injury, multiple sclerosis, stroke, trauma or other brain injury. Conditions that interfere with the individual's ability to voluntarily void the bladder may also arise post-surgically or as a result of benign prostatic hypertrophy or diabetes. Many of the affected individuals are capable of, and would prefer to perform self-catheterization. For many, the level of risk and discomfort of repeated catheterizations carried out over the course of a day (at 3-6 hour intervals, for example) are offset by the accompanying convenience, privacy or self-reliance that is achieved. Some of the major difficulties that arise in self-catheterization are the lack of satisfactory cathaterization kits, the problem of maintaining the required level of sanitation during the procedure, and the difficulty of sometimes performing the procedure under conditions of restricted space and privacy.
In assisted, or non self-catheterizations, it is common practice in hospitals to employ a catheterization tray, which typically includes a sterile drape, gloves, a conventional catheter, antiseptic solution, swabs, lubricant, forceps, underpad and a urine collection container. Assisted catheterization is usually performed with the patient in a supine position. Maintaining a sterile field during the procedure can still be a problem, however, and the "cath tray" procedure is impractical for use with some individuals and situations today.
Since it is inconvenient and thus undesirable to have to use a conventional cath tray and maintain strictly sterile technique, there have been many efforts in the past to simplify the catheterization procedure, and to "unitize" the equipment to facilitate sanitary practice and to make urine collection easier and quicker. For example, U.S. Pat. No. 4,230,115, issued to Walz, Jr. et al., describes a catheter and collection receptacle combination in which the catheter is initially enclosed in a sterile bag. U.S. Pat. No. 4,246,909, issued to Wu et al., describes another catheter within a collection bag, the bag also having means for isolating a clean urine specimen. U.S. Pat. No. 4,652,259, issued to O'Neil, is for a catheter assembly designed to prevent carrying periurethral microorganisms into the upper urethra and bladder along with the catheter. U.S. Pat. No. 5,147,341, issued to Starke et al., is drawn to another catheter and collection bag combination that provides for transiting the periurethral region prior to introduction of the catheter.
The catheters of many of the prior art devices are lubricated just before use by means of a tube of conventional lubricant, such as K-Y Jelly.TM., after removal from their sterile packaging. This practice is not only inconvenient, but is a potential source of microbial contamination. U.S. Pat. No. 5,209,726, issued to Goosen, describes one type of self-lubricating catheter enclosed in a type of close-fitting flexible sheath. Upon insertion into the urethra, the lubricant-filled sheath collapses upon the catheter and forces lubricant out the tip of the catheter and along the urethra, as the catheter progresses inwardly toward the bladder. U.S. Pat. No. 5,226,530, issued to Golden, is for a catheter with its pre-lubricated tip partially enclosed in a smaller secondary package. The smaller package serves to localize the lubricant on the tip area and to prevent the lubricant from spreading throughout the interior of the larger package and over the entire catheter. U.S. Pat. No. 5,582,599, issued to Daneshvar, has a type of clear protective cover assembly intended, in part, to prevent contamination of the catheter during handling. The catheter is grasped through a type of flexible cover, that may have interior projections to facilitate grasping a prelubricated or medicated catheter. U.S. Pat. No. 3,894,540, issued to Bonner, Jr., is for a catheter designed for intermittent use, having a collapsable flexible cover that deters bending or kinking of the catheter.
Many individuals with spinal cord injuries or other neurological diseases routinely perform intermittent catheterization several times a day using conventional catheters or kits and "clean technique." Clean technique means that the urethral area is initially swabbed with antiseptic, and efforts are made to avoid contamination of the catheter during the procedure. The user's hands are not sterile and a sterile field is not maintained. Clean technique is used instead of sterile technique, generally, for two reasons. First, it is very difficult, if not impossible, for individuals who are performing self-catheterization to adhere strictly to sterile technique. Secondly, these individuals are required to catheterize themselves between 3 and 6 times a day, and the cost of a new sterile catheter and the accessories required to perform sterile catheterization becomes excessively expensive for some users. Sometimes an individual will reuse a "cleaned" catheter. As a result, the use of "clean technique" will many times result in contamination and subsequent infection of the urinary tract, causing significant morbidity and cost to the patient and society.
Even if cost considerations were not a major consideration for the user, with most of the prior art self-contained sterile units where the collection bag doubles as the catheter insertion cover, the catheter is extremely difficult for the user to grasp and insert. This is particularly a problem for self-catheterization users who may also have neurologic problems that limit manual dexterity. Also, with some of the available catheter kits and methods, the catheter is either not sufficiently lubricated during insertion (and thus requires the additional application of possibly non-sterile lubricant), or the catheter is too slick with lubricant and cannot effectively be grasped through the insufficiently flexible bag. As a practical matter, most individuals who would prefer to self-catheterize cannot do so using the existing apparatus while maintaining the required level of sanitation.
Another difficulty with the prior art's propensity for merely sterilely packaging the catheter inside the urine collection bag is that the flexible bag is typically neither thin-walled and pliant enough to permit grasping and feeding the catheter into the urethra, nor is it sufficiently rigid for accurate urine output measurement or for specimen removal. With some of the available catheter kits, there is also the further problem of the proximal end of the catheter tending to drop down into the collection bag. In this circumstance, the user must first maneuver the catheter tip back to the bag opening before the catheter can be inserted into the patient's urethral opening.
Accordingly, there is a need for an easy-to-use disposable catheter system that is economically practical for use for temporary catheterizations by individuals or by health care providers in hospitals, mobile emergency facilities, doctors' offices, rehabilitation facilities, nursing homes and the like. Also, there is a need for a disposable catheter assembly that provides substantial ease of use for self-catheterization, in the home or in a public restroom, and that provides a high degree of sanitation during handling and use. Moreover, if an easier to use catheterization kit were available that could be economically manufactured and purchased for one time only use, the incidence of urethral and bladder infections in catheterization patients would undoubtedly improve.